District court upholds US patent for Gilenya

Mitsubishi Tanabe Pharma (TYO: 4508) has announced that the US District Court of Delaware has ruled that its patent covering Gilenya (fingolimod hydrochloride) is valid, and that no generic drug may be approved in the USA before February 2019.

The ruling is the result of a patent infringement lawsuit brought by the Japanese pharma major against six generics manufacturers: Allergan (NYSE: AGN), Apotex, Aurobindo Pharma (BSE: 524804), Ezra Ventures, HEC Pharm and Mylan Pharmaceuticals (Nasdaq: MYL).

The case was jointly brought by Mitsubishi Tanabe with Swiss group Novartis (NOVN: VX), which holds the rights to the product in the USA, and Mitsui & Co (TYO: 8031), a joint patent holder, after the six generics firms had filed abbreviated New Drug Applications arguing the patent was not enforceable.

Gilenya is a treatment for multiple sclerosis that has been marketed in the USA since 2010. It’s approved in over 80 countries including Canada, Japan and EU member states.